The AQUAMARINE EPA/DHA Study

JRCT ID: jRCTs051180125

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Coronary heart disease
• Date of first enrollment: 17/08/2015
• Target sample size: 150
• Study type: Interventional

Intervention(s)

2-g group: Subjects will take 2 g of omega-3-acid ethyl esters once daily, immediately after meal.
4-g group: Subjects will take 2 g of omega-3-acid ethyl esters twice daily, immediately after meal.
No-treatment group: Subjects will not take omega-3-acid ethyl esters.

Outcome(s)

• Primary Outcome: Change in plaque to myocardium ratio (PMR) in the primary lesion measured by non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging (change at study completion or discontinuation from baseline)

Secondary Outcome

Change in plaque to myocardium ratio (PMR) in all lesions measured by non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging (change at study completion or discontinuation from baseline)

Percent change in plaque to myocardium ratio (PMR) in the primary lesion measured by non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging (percent change at study completion or discontinuation from baseline)

Percent change in plaque to myocardium ratio (PMR) in all lesions measured by non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging (percent change at study completion or discontinuation from baseline)

Changes in Hounsfield units, plaque volume, vessel area, and plaque area in the primary lesion measured by computed tomography angiography (CTA) (change at study completion or discontinuation from baseline)

Changes in Hounsfield units, plaque volume, vessel area, and plaque area in all lesions measured by computed tomography angiography (CTA) (change at study completion or discontinuation from baseline)

Percent changes in Hounsfield units, plaque volume, vessel area, and plaque area in the primary lesion measured by computed tomography angiography (CTA) (percent change at study completion or discontinuation from baseline)

Percent changes in Hounsfield units, plaque volume, vessel area, and plaque area in all lesions measured by computed tomography angiography (CTA) (percent change at study completion or discontinuation from baseline)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Subjects must meet all of the following criteria.
1.Diagnosed with hyperlipidemia and receiving instructions for lifestyle modification
2.Diagnosed with coronary artery disease and have coronary stenosis exceeding 25%, as measured by computed tomography angiography (CTA) or invasive coronary angiography (CAG).
3.Have been taking an HMG-CoA reductase inhibitor at a fixed dose and administration method from at least 4 weeks before informed consent
4.Have at least one coronary plaque with a plaque to myocardium ratio (PMR) of 1.0 or more in non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging at the screening test
5.Serum LDL-cholesterol level less than 100 mg/dL at the screening test
6.Age less than 20 years at the time of consent
7.Capable of visiting the study centers on an outpatient basis
8.Capable of providing written consent before participation in this study

Exclude criteria

1.Use of EPA preparation within 12 weeks before informed consent
2.Scheduled to undergo percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) during the observation period
3.Presence of type 1 diabetes mellitus or type 2 diabetes mellitus with uncontrolled hyperglycemia (HbA1C more than 8.0%)
4.Clinically apparent impairment of renal function
5.Presence of bleeding (e.g., hemophilia, capillary fragility, gastrointestinal tract ulcer, urinary tract bleeding, hemoptysis, vitreous hemorrhage)
6.History of hypersensitivity to any component of the investigational product
7.Other patients who are inappropriate for participation in this study in the opinion of the principal investigator or investigator.

Related Information

• Primary Sponsor: Yasuda Satosi
• Source(s) of Monetary Support: Takeda Pharmaceutical Company Limited.
• Secondary ID(s): UMIN000015316